Overview

A drug product is classified as a Generic - OTC in one country and the same is recognized as a Generic - Prescription by the Health Authority (HA) of another country. At such times a company cannot afford any misinterpretation, and thus they are required to have necessary knowledge before proceeding for their business expansion. Whether it is knowing about dossier requirement or import regulations for their drug products, a pharma company must be aware of all the necessary geo-specific requirements. A proactive approach and Regulatory Intelligence(RI) to acquire a comprehensive overview of the Regulatory landscape of a country is the need of the hour for drug makers and sellers.

Freyr’s RI team understands the importance of Regulatory information, and how accurate information can make a difference in the success of a company. Starting from addressing any focused Regulatory query, overview of any country’s regulations or to assess the Regulatory needs prior to product registration, Freyr tailors its RI solution for drug category to meet diverse needs of global pharmaceutical and biopharmaceutical companies. Freyr has divided drug product category into further sub-categories:

  • New Chemical Entity / New Molecule Entity (NCE/NME)
  • Generic- Prescription
  • Generic- OTC
  • Biologics
  • Biosimilars
  • Vaccines
  • Orphan Drugs
  • Traditional Medicines
 

Freyr Expertise

  • Regulatory overview of the country
  • Product categorization and classification
  • Registration requirements
  • Labeling and packaging requirements
  • Clinical study requirements
  • GxP requirements
  • Import regulations
  • Local agent requirement
  • Post-marketing authorization
 

Freyr Advantages

  • Skilled and experienced Regulatory professionals
  • Proven expertise in:
    • Regulatory analysis and assessment
    • Regulatory report writing
    • Regulatory secondary research
    • Regulatory primary research